Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03

FDA recall notice · announced July 14, 2021 · Alvogen

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03

Reason for recall

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

Notes

Distribution: USA nationwide.
Lot/code information: Lot #: 36924, Exp 6/2021
Quantity: 9,696 cartons
Status: Terminated
Products in this recall event:
- Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03 (D-0649-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.